The following data is part of a premarket notification filed by Geister Medizintechnik Gmbh with the FDA for Geister Surgical Int'l Bipolar Endoscopic Surgical Instruments.
| Device ID | K933699 |
| 510k Number | K933699 |
| Device Name: | GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GEISTER MEDIZINTECHNIK GMBH 203 MAIN ST. SUITE A-166 Flemington, NJ 08822 |
| Contact | Lynette L Howard |
| Correspondent | Lynette L Howard GEISTER MEDIZINTECHNIK GMBH 203 MAIN ST. SUITE A-166 Flemington, NJ 08822 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-29 |
| Decision Date | 1994-01-27 |